No matter if you’re while in the merchandise preparing, development or pharmaceutical lifecycle management phase or have to have a remediation technique for a compliance disaster, Regulatory Compliance Associates will guide you thru each pharmaceutical consulting phase in the regulatory method.
Gap Investigation is usually a classical consulting Instrument to align The existing With all the concentrate on position. It relates both to the whole GMP technique of the regulated corporation or to individual subareas.
We assist A huge number of firms, including seventeen of the top twenty five world pharmaceutical, biotech, and clinical system firms, hook up Using the experts they need to have throughout the optimal workforce product.
Functioning through the First improvement action stage, prospect variety, via scale up and technical transfer into your manufacturing unit network, our abilities in validation and microbial evaluation in the manufacturing system, danger assessments and clinical trial styles may be a must have when placed on your portfolio.
Produce and disseminate evidence that solutions critical medical, regulatory and business inquiries, enabling you to definitely generate smarter selections and meet your stakeholder needs with self-assurance.
We've been deeply skilled GxP consultants, auditors and practitioners. We proactively help pharmaceutical and healthcare unit companies throughout the world with all components of their producing and provide chain good quality assurance and linked enterprise process optimisation.
Our GMP gurus have experience auditing techniques in opposition to applicable regulatory and industry requirements. Our gurus work along with you to use the right expectations determined by your needs, the routines or providers presented, along with the phase of one's project.
Regulatory affairs read more is Regulatory Compliance Associates spine. We exceed other pharma consulting companies with sector gurus expert in complexities of the pharmaceutical and biopharmaceutical industries.
We are able to as a result offer you this consulting assistance in Every single manner standard out there. The design evaluate can website often be completed with out a corresponding on-web-site presence, solely based on the complex documentation about the general and thorough scheduling of an installation.
Upon ask for, the respective regulatory authority will carry out an on-web page inspection to validate compliance with countrywide regulation and EU GMP specifications.
Most FDA GMP consultants may have GMP consulting expertise which is a crucial qualification considering that they've experienced prospects to work with quite a few organizations and in different settings. The significance of operational knowledge, on the other hand, really should not be ignored.
Please tick this box if you agree to periodic updates from Rephine. You may unsubscribe at any time.
Get in connection with us now and tell us wherein steps of GMP thought development you'll need support. We're going to promptly offer you a suggestion for consulting services or creation of a concept. Alongside one another we find The best options in your undertaking!
We are going to publish your provider acceptance system, function along with you to implement it, and teach you to help keep it working.